In October 23, a total of 221 medical device products were approved by China National Medical Product Administration (NMPA). Among them, there are 176 domestic Class III medical device products, 28 imported Class III medical device products, 16 imported Class II medical device products, and 1 Hong Kong, Macao and Taiwan medical device product.
China is re-opening to the world after COVID isolation in 2023. As the only double-digit growth country in MedTech, 2nd largest market in the world, China market entry has its challenges to enter and sustain the growth. Leveraging our extensive experience, China Med Device provides regulatory, CRO and commercialization one-stop solutions for medical device, IVD, CDx and combination products in China. Connect with us by emailing info@ChinaMedDevice.com to schedule an exploratory call and discover how our expertise can benefit your ventures in the thriving Chinese healthcare landscape.
Here is the complete list of imported products approved by China NMPA in October 2023.
| Approved Class III Imported Products | |
| Product Name | Registrant/Manufacturer |
| Cutting Base Columns | Institut Straumann AG |
| Artificial lens | Alcon Laboratories, Incorporated |
| Radial Artery Access Distal Access Catheter | Micro Therapeutics, Inc. DBA ev3 Neurovascular |
| Oil for assisted reproduction cultures | FUJIFILM Irvine Scientific, Inc. |
| Carbon dioxide laser therapy machine | Asclepion Laser Technologies GmbH |
| Ultrasonic suction equipment | Integra LifeSciences (Ireland) Ltd |
| Single-use plasma surgical electrodes | ArthroCare Corporation |
| Continuous Blood Gas Monitoring Connector | Terumo Cardiovascular Systems Corporation |
| Toric depth-of-focus extension IOLs | Johnson & Johnson Surgical Vision, Inc. |
| Continuous Peripheral Ultrasound Guided Nerve Block Kit | B. Braun Melsungen AG |
| Intermaxillary fixation system | Synthes GmbH |
| X-ray computed tomography equipment | Siemens Healthcare GmbH |
| Peripheral Vascular Occlusion Balloon Catheter | LeMaitre Vascular, Inc. |
| Blocking Balloon Catheter | Stryker Neurovascular |
| Absorbable Wound Suture | Covidien llc |
| coronary balloon dilatation catheter | Genoss Co., Ltd. |
| Abutments and accessories | APEIRON DENTAL S.r.l |
| Disposable Needle for Injection Pen | Becton Dickinson and Company |
| Disposable Membrane Oxygenator | Medtronic, Inc. |
| Knee prosthesis components – femoral components | Zimmer Inc. |
| Tendon ligament fixation screws | ConMed Corporation |
| rigid scleral contact lens | Valley Contax Inc. |
| Single-Use Extracorporeal Circulation Tap Sensor | Terumo Cardiovascular Systems Corporation |
| Hip prosthesis – double-action acetabular liner | Howmedica Osteonics Corp. |
| Intestinal laminating stents | M.I.Tech Co., Ltd. |
| Disposable Blood Component Separator | Fresenius Kabi AG |
| Peripherally indented balloon dilatation catheter | Bard Peripheral Vascular, Inc. |
| Oil for assisted reproduction | Vitrolife Sweden AB |
| Approved Class II Imported Products | |
| Single-use clamping device | Olympus Media Systems, Inc. |
| Disposable Subcutaneous Tunneling Tool | Medtronic Inc. |
| Magnetic field therapy equipment | BTL Industries Limited |
| cochlear implant sound processor | Cochlear Limited |
| Electric operating table | TRUMPF Medizin Systeme GmbH + Co. KG |
| Handles and accessories for surgical power systems | Medtronic Powered Surgical Solutions |
| Fully automated chemiluminescence immunoassay analyzer | Roche Diagnostics GmbH |
| Non-absorbable surgical sutures | Assut Europe S.p.A. |
| Dental implant drills | DENTIS. |
| Single-use sterile protective cover | microtek medical, inc. |
| Body Composition Analyzer | InBody Co., Ltd. |
| Dental implant drills | ALTATEC GmbH |
| Non-absorbable sutures | Ethicon, LLC |
| nasopharyngeal airway | Covidien llc |
| Semiconductor laser therapy | Theradome Inc. |
| Automatic Biochemistry Analyzer | Roche Diagnostics GmbH |
